Senior Manager, Clinical Quality

EPM Scientific; Florham Park (NJ); On-site; USD 150,000 - 190,000; Full time

Job summary

EPM Scientific partners with a growing bio-pharmaceutical company to recruit a Senior Manager, Clinical Quality. This role provides quality oversight across clinical studies and vendor programs, ensuring GCP compliance and inspection readiness throughout the clinical development lifecycle.

The ideal candidate brings 5+ years in GCP QA/Clinical Quality, with deep knowledge of ICH-GCP, FDA, EMA, and global regulations, plus strong auditing and CAPA management capabilities.

Qualifications

• Bachelor's degree in Life Sciences or related field is required.
• 5+ years of GCP QA, Clinical Quality, or Compliance experience preferred.
• Strong knowledge of ICH-GCP, FDA, EMA, and global clinical regulations is essential.

Responsibilities

• Provide GCP quality oversight for clinical studies, CROs, and vendors.
• Partner with study teams to identify quality risks and implement mitigation strategies.
• Conduct and manage GCP audits, including CRO, vendor, investigator site, and TMF audits.
• Support regulatory inspections, CAPAs, and inspection readiness activities.
• Review clinical processes and documentation to ensure compliance with global regulations.
• Serve as a quality advisor to cross-functional teams on GCP and compliance matters.

Skills

GCP QA

Clinical Quality

Compliance

GCP audits

CAPAs

Inspection readiness

ICH-GCP

FDA/EMA regs

Regulatory knowledge

Communication

Collaboration

Problem-solving

Education

Bachelor's degree in Life Sciences

Job description

A growing bio-pharmaceutical company is seeking a Senior Manager, Clinical Quality to provide quality oversight across clinical studies and vendor programs.

This role will partner closely with clinical teams, CROs, and vendors to ensure GCP compliance, support inspection readiness, and drive quality throughout the clinical development life cycle. The ideal candidate will bring strong auditing experience, a risk-based mindset, and deep knowledge of global clinical regulations.

What You’ll Do

The Opportunity

A growing bio-pharmaceutical company is seeking a Senior Manager, Clinical Quality to provide quality oversight across clinical studies and vendor programs.

This role will partner closely with clinical teams, CROs, and vendors to ensure GCP compliance, support inspection readiness, and drive quality throughout the clinical development life cycle. The ideal candidate will bring strong auditing experience, a risk-based mindset, and deep knowledge of global clinical regulations.

What You’ll Do

• Provide GCP quality oversight for clinical studies, CROs, and vendors.
• Partner with study teams to identify quality risks and implement mitigation strategies.
• Conduct and manage GCP audits, including CRO, vendor, investigator site, and TMF audits.
• Support regulatory inspections, CAPAs, and inspection readiness activities.
• Review clinical processes and documentation to ensure compliance with global regulations.
• Serve as a quality advisor to cross-functional teams on GCP and compliance matters.

What You’ll Bring

• Bachelor's degree in Life Sciences or a related field.
• 5+ years of GCP QA, Clinical Quality, or Compliance experience.
• Strong knowledge of ICH-GCP, FDA, EMA, and global clinical regulations.
• Experience performing GCP audits and vendor oversight activities.
• Proven ability to manage CAPAs, compliance risks, and inspection readiness efforts.
• Strong communication, collaboration, and problem-solving skills.